Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
Phase 4
- Conditions
- Cough Variant Asthma
- Interventions
- Registration Number
- NCT01170429
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).
- Detailed Description
This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.
During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- male or female patients,18-75 years old;
- cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
- without wheeze and fever;
- without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
- without rales from lung;
- no obvious abnormalities from chest X-ray;
- bronchial provocation test: positive.
Exclusion Criteria
- patients with chronic pulmonary disease;
- patients who are allergic to ß2 receptor agonist;
- patients taking ß2 receptor agonist for long time;
- severe heart, renal and hepatic disease;
- unable to comply with the protocol;
- pregnant, breast feeding, and childbearing potential women;
- patients improper to the trial according to the investigators' judgment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I. Procaterol Hydrochloride Procaterol hydrochloride Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; II. Procaterol hydrochloride placebo Meptin placebo Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
- Primary Outcome Measures
Name Time Method Patient cough symptom score 8 weeks Therapy duration 8 weeks Rates of adverse events 8 weeks
- Secondary Outcome Measures
Name Time Method LCQ Life Quality Score 8 weeks
Trial Locations
- Locations (1)
Xin Zhou
🇨🇳Shanghai, Shanghai, China